FDA Adverse Event
Injury
Summary report: N
KAPPA 700 SR
MDR report key: 3242982
·
Received July 23, 2013
Report
- Report Number
- 2647346-2013-00080
- Event Type
- Injury
- Date Received
- July 23, 2013
- Report Date
- June 27, 2013
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO, MED REL
- Product Code
- NVZ
- PMA / PMN Number
- P980035
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DE, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCT: 5076 IMPLANTABLE PACING LEAD, IMPLANTED (B)(6) 2001. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THE IMPLANTABLE PULSE GENERATOR (IPG) DEPLETED MORE RAPIDLY THAN EXPECTED. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 342131 | KAPPA 700 SR | PULSE GENERATOR, PERMANENT, IMPLANTABLE | NVZ | MDT PUERTO RICO OPERATIONS CO, MED REL | KSR701 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |